Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID a24d6d03-9021-187a-e053-2a95a90af000

Route

TOPICAL

Published

Effective Date 2020-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Benzalkonium (0.1 g)

Inactive Ingredients

Glycerin Sodium Benzoate Water Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-21

Description

Benzalkonium Chloride

Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

Dosage and Administration

for external use only

Description

Benzalkonium Chloride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

Section 51945-4

Section 55105-1

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9

Benzalkonium Chloride

Structured Label Content

Indications and Usage (34067-9)

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9 (55106-9)

Benzalkonium Chloride

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry. Supervise children in the use of this product. Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry", "34068-7": "for external use only", "34071-1": "For external use only. Flammable, keep away from fire or flame. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid", "55105-1": "Antiseptic instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease instant hand antiseptic to decrease bacteria on the skin recommended for repeated use hand sanitizer to help reduce bacteria on the skin", "55106-9": "Benzalkonium Chloride"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:09.504295 · Updated: 2026-03-14T22:56:07.308923